Access to European Union law
<a href="https://eur-lex.europa.eu/content/help/eurlex-content/experimental-features.html" target="_blank">More about the experimental features corner</a>
Choose the experimental features you want to try
EUR-Lex
Access to European Union law

This document is an excerpt from the EUR-Lex website

You are here
Use quotation marks to search for an "exact phrase". Append an asterisk (*) to a search term to find variations of it (transp*, 32019R*). Use a question mark (?) instead of a single character in your search term to find variations of it (ca?e finds case, cane, care).
Search tips
Need more search options? Use the Advanced search

Document 52010AP0332

    Pharmacovigilance (amendment of Directive 2001/83/EC) ***I European Parliament legislative resolution of 22 September 2010 on the proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (COM(2008)0665 – C6-0514/2008 – 2008/0260(COD))
    P7_TC1-COD(2008)0260 Position of the European Parliament adopted at first reading on 22 September 2010 with a view to the adoption of Directive 2010/…/EU of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use

    OJ C 50E, 21.2.2012, p. 72–73 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    21.2.2012   

    EN

    Official Journal of the European Union

    CE 50/72

    Wednesday 22 September 2010
    Pharmacovigilance (amendment of Directive 2001/83/EC) ***I

    P7_TA(2010)0332

    European Parliament legislative resolution of 22 September 2010 on the proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (COM(2008)0665 – C6-0514/2008 – 2008/0260(COD))

    2012/C 50 E/16

    (Ordinary legislative procedure: first reading)

    The European Parliament,

    —

    having regard to the Commission proposal to the European Parliament and the Council (COM(2008)0665),

    —

    having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C6-0514/2008),

    —

    having regard to the Communication from the Commission to the European Parliament and the Council entitled ‘Consequences of the entry into force of the Treaty of Lisbon for ongoing interinstitutional decision-making procedures’ (COM(2009)0665),

    —

    having regard to Article 294(3) and Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union,

    —

    having regard to the opinion of the European Economic and Social Committee of 10 June 2009 (1),

    —

    having regard to the opinion of the Committee of the Regions of 7 October 2009 (2),

    —

    having regard to the undertaking given by the Council representative by letter of 23 June 2010 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

    —

    having regard to Rule 55 of its Rules of Procedure,

    —

    having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection (A7-0159/2010),

    1.

    Adopts its position at first reading hereinafter set out;

    2.

    Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;

    3.

    Instructs its President to forward its position to the Council, the Commission and the national parliaments.

    (1)  OJ C 306, 16.12.2009, p. 28.

    (2)  OJ C 79, 27.3.2010, p. 50.

    Wednesday 22 September 2010
    P7_TC1-COD(2008)0260

    Position of the European Parliament adopted at first reading on 22 September 2010 with a view to the adoption of Directive 2010/…/EU of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use

    (As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive 2010/84/EU.)

    Top